A Phase 2 Study of SGB-9768 in Patients With Paroxysmal Nocturnal Hemoglobinuria

August 27, 2026 updated by: Suzhou Sanegene Bio Inc.

A Multicenter, Randomized, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Multiple Doses of SGB-9768 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

This is a multicenter, randomized, open-Label Phase II study to evaluate the efficacy and safety of multiple doses of SGB-9768 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants ≥ 18 years of age;
  2. Diagnosis of PNH confirmed by flow cytometry, with a PNH clone size >10% in granulocytes and/or monocytes;
  3. Mean hemoglobin level <100 g/L at screening.
  4. LDH > 1.5 x Upper Limit of Normal (ULN) at screening.
  5. Complement inhibitor-naïve, or previous complement inhibitor therapy discontinued for more than 5 drug half-lives or 3 months before randomization.
  6. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

  1. Patients with reticulocytes <100x10⁹/L; platelets <30x10⁹/L; neutrophils <0.5x10⁹/L.
  2. History of congenital asplenia or splenectomy.
  3. Known or suspected hereditary or acquired complement deficiencies/abnormalities.
  4. Active or recurrent invasive infections caused by encapsulated bacteria (e.g., Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae).
  5. Active systemic bacterial, viral, or fungal infection within 14 days before randomization.
  6. Evidence or history of tuberculosis infection (except adequately treated inactive tuberculosis with negative screening results).
  7. Recurrent chronic infections within 1 year before screening.
  8. Positive virology tests indicating active HBV, HCV, HIV, or syphilis infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Participants will receive multiple doses of SGB-9768.
Drug: SGB-9768
SGB-9768 will be administered by subcutaneous injection.
Experimental: Arm 2
Participants will receive multiple doses of SGB-9768.
Drug: SGB-9768
SGB-9768 will be administered by subcutaneous injection.
Experimental: Arm 3
Participants will receive multiple doses of SGB-9768.
Drug: SGB-9768
SGB-9768 will be administered by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean LDH change from baseline
Time Frame: weeks 18-24
weeks 18-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Sanegene Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGB-9768-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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